(155 days)
Not Found
No
The document describes a laser device for surgical procedures and does not mention any AI or ML capabilities.
Yes.
This device is clearly intended for therapeutic use, as described by its various indications for incision, excision, vaporization, hemostasis, coagulation, and ablation of soft tissues across numerous medical specialties for the treatment of various conditions.
No
This device is intended for surgical procedures such as incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue, not for diagnosis.
No
The device is a laser, which is a hardware device that emits light energy for surgical procedures. The description focuses on the physical delivery of laser light and its effects on tissue, not on software functionality as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a laser intended for the delivery of laser light to soft tissue during surgical procedures. It is used for direct interaction with the patient's body for therapeutic purposes (incision, excision, vaporization, ablation, hemostasis, coagulation, etc.).
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient. Its function is to apply energy directly to tissue.
Therefore, this device falls under the category of a surgical laser, which is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The Ceralas Multiwavelength 980/1470nm Diode Laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein. The Multiwavelength laser is further indicated for laser assisted lipolysis.
The device is specifically indicated for use as follows:
Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:
. Removal of benign lesions from the ear, nose and throat
Excision and vaporization of vocal cord nodules and polyps .
. Incision and excision of carcinoma in situ
Ablation and vaporization of hyperkeratosis .
Excision of carcinoma of the larynx .
. Laryngeal papillomectomy
Excision and vaporization of herpes simplex I and II ●
Neck dissection .
Arthroscopy
Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include:
Menisectomy
. Synovectorny
Chondromalacia ●
Gastroenterology
Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:
. Hemostasis of upper and lower GI bleeding
. Excision and vaporization of colorectal carcinoma
Excision of polyps
General Surgery, Dermatology, Plastic Surgery and Podiatry
Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include:
Matrixectomy .
Excision of neuromas .
Excision of periungual and subungual warts ●
Excision of plantar warts
Excision of keloids
. Liver resection
. Excision of cutaneous lesions
. Hemorrhoidectomy
. Appendectomy
. Debridement of decubitus ulcers
. Hepatobiliary tumors
. Mastectomy
. Dermabrasion
. Vaporization and hemostasis of capillary hemangioma
Excision, vaporization and hemostasis of abdominal tumors .
. Excision, vaporization and hemostasis of rectal pathology
Pilonidal cystectomy .
. Herniorapphy
. Adhesiolysis
. Parathyroidectomy
. Laparoscopic cholecystectomy
. Thyroidectomy
. Resection of organs
. Debridement of wounds
Photocoagulation of teleangectasia of the legs and face .
Photocoagulation of vascular lesions of the face and extremities .
Endovascular coagulation of the greater saphenous vein of the thigh in ● patients with superficial vein reflux.
. Treatment of reticular veins and branch varicosities
Urology
Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include:
. Vaporization of urethral tumors
Release of urethral stricture .
. Removal of bladder neck obstruction
Excision and vaporization of condyloma .
Lesions of external genitalia ●
Vaporization of the prostate to treat benign prostatic hyperplasia (BPH) .
Gynecology
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:
Endometrial ablation .
Excision or vaporization of condylomata acuminate .
Vaporization of cervical intraepithelial neoplasia .
Cervical conization .
Menorrhagia
Neurosurgery
Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas
Cardiac Surgery
Hemostasis and coagulation of soft tissue, including cardiac tissue.
Pulmonary Surgery
Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:
. Tracheobronchial malignancy or stricture
Benign and malignant pulmonary obstruction .
Endoscopic pulmonary applications
Dental Applications
Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.
Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux
Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.
Product codes
GEX
Device Description
The Ceralas Multiwavelength 980/1470 Diode Laser emits laser energy at the 980nm and 1470nm wavelengths in a manner substantially similar to the Ceralas 980 and Ceralas 1470.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear, nose, throat, oral cavity, joint tissues, upper and lower gastrointestinal tracts, skin, abdominal, rectal, fat, muscle, urological tissues, gynecological tissue, brain (in conjunction with meningiomas), cardiac tissue, pulmonary system, intraoral and extraoral soft tissue, greater saphenous vein, teeth.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing of the Ceralas Multiwavelength 980/1470 Diode Laser demonstrates no significant difference as compared to the cleared predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
090164 Page (1) of (5)
510(k) SUMMARY
Biolitec Inc.'s Ceralas Multiwavelength 980/1470nm Diode Laser System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Hogan & Hartson 555 13th Street NW Washington DC 20004
JUN 26 2009
(202) 637-5794 Phone: Facsimile: (202) 637-5910
Jonathan S. Kahan Contact Person:
January 21, 2009 Date Prepared:
Name of Device and Name/Address of Sponsor
Ceralas Multiwavelength 980/1470nm Diode Laser
Biolitec, Inc. 515 Shaker Road East Longmeadow, MA 01028
Common or Usual Name
Diode Laser
Classification Name
Laser, Surgical Diode Laser System, 21 C.F.R. 878.4810, Product Code GEX
Predicate Devices
Cynosure Smart Lipo Multiwavelength Laser (K080121) Biolitec Ceralas 980nm Diode Laser (K072106) Biolitec Ceralas 1470nm Diode Laser (K073063)
\ \ \ \ DC - 061213/00001 - 2831829 v2
1
090164 page (2) of (5)
Intended Use / Indications for Use
The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The Ceralas Multiwavelength 980/1470nm Diode Laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein. The Multiwavelength laser is further indicated for laser assisted lipolysis.
The device is specifically indicated for use as follows:
Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:
- . Removal of benign lesions from the ear, nose and throat
- Excision and vaporization of vocal cord nodules and polyps .
- . Incision and excision of carcinoma in situ
- Ablation and vaporization of hyperkeratosis .
- Excision of carcinoma of the larynx .
- . Laryngeal papillomectomy
- Excision and vaporization of herpes simplex I and II ●
- Neck dissection .
Arthroscopy
Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include:
- Menisectomy
- . Synovectorny
- Chondromalacia ●
Gastroenterology
Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:
- . Hemostasis of upper and lower GI bleeding
- . Excision and vaporization of colorectal carcinoma
- � Excision of polyps
2
K090164 Page 3 of (5)
General Surgery, Dermatology, Plastic Surgery and Podiatry
Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include:
- Matrixectomy .
- Excision of neuromas .
- Excision of periungual and subungual warts ●
- Excision of plantar warts �
- Excision of keloids �
- . Liver resection
- . Excision of cutaneous lesions
- . Hemorrhoidectomy
- . Appendectomy
- . Debridement of decubitus ulcers
- . Hepatobiliary tumors
- . Mastectomy
- . Dermabrasion
- . Vaporization and hemostasis of capillary hemangioma
- Excision, vaporization and hemostasis of abdominal tumors .
- . Excision, vaporization and hemostasis of rectal pathology
- Pilonidal cystectomy .
- . Herniorapphy
. Adhesiolysis
- . Parathyroidectomy
- . Laparoscopic cholecystectomy
- . Thyroidectomy
- . Resection of organs
- . Debridement of wounds
- Photocoagulation of teleangectasia of the legs and face .
- Photocoagulation of vascular lesions of the face and extremities .
- Endovascular coagulation of the greater saphenous vein of the thigh in ● patients with superficial vein reflux.
- . Treatment of reticular veins and branch varicosities
Urology
Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include:
- Vaporization of urethral tumors .
- Release of urethral stricture .
- . Removal of bladder neck obstruction
- Excision and vaporization of condyloma .
- Lesions of external genitalia ●
- Vaporization of the prostate to treat benign prostatic hyperplasia (BPH) .
3
090164 Page (4) of (5)
Gynecology
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:
- Endometrial ablation .
- Excision or vaporization of condylomata acuminate .
- Vaporization of cervical intraepithelial neoplasia .
- Cervical conization .
- Menorrhagia �
Neurosurgery
Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas
Cardiac Surgery
Hemostasis and coagulation of soft tissue, including cardiac tissue.
Pulmonary Surgery
Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:
- . Tracheobronchial malignancy or stricture
- Benign and malignant pulmonary obstruction .
- Endoscopic pulmonary applications �
Dental Applications
Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.
Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux
Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.
4
091164 Page (5) of (5)
Technological Characteristics
The Ceralas Multiwavelength 980/1470 Diode Laser emits laser energy at the 980nm and 1470nm wavelengths in a manner substantially similar to the Ceralas 980 and Ceralas 1470.
Performance Data
Performance testing of the Ceralas Multiwavelength 980/1470 Diode Laser demonstrates no significant difference as compared to the cleared predicate devices.
Substantial Equivalence
The Ceralas Multiwavelength 980/1470nm Diode Laser is substantially equivalent to the Cynosure Smart Lipo Multiwavelength Laser, the Biolitec Ceralas 980mm Diode Laser and the Ceralas 1470nm Diode Laser. The Ceralas Multiwavelength 980/1470mm Diode Laser has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Ceralas Multiwavelength 980/1470mm Diode Laser and its predicate devices raises no new issues of safety or effectiveness. Thus, the Ceralas Multiwavelength 980/1470nm Diode Laser is substantially equivalent.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
JUN 26 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biolitec, Inc. % Hogan & Hartson LLP Mr. Jonathan S. Kahan Columbia Square 555 13th Street Northwest Washington, District of Columbia 20004
Re: K090164
Trade/Device Name: Ceralas Multiwavelength 980/147nm Diode Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 2, 2009
Dear Mr. Kahan:
Received: June 3, 2009
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
6
Page 2 - Mr. Jonathan S. Kahan
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark McMillan
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use Statement
| 510(k) Number (if known):_ | KC |
|---|---|
| ---------------------------- | ---- |
Device Name: Ceralas Multiwavelength 980/1470nm Diode Laser
90164
Indications for Use:
The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The Ceralas Multiwavelength 980/1470 Diode Laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein. Multiwavelength laser is further indicated for laser assisted lipolysis
The device is specifically indicated for use as follows:
Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:
- Removal of benign lesions from the ear, nose and throat .
- Excision and vaporization of vocal cord nodules and polyps
- Incision and excision of carcinoma in situ
- Ablation and vaporization of hyperkeratosis
- Excision of carcinoma of the larynx
- Laryngeal papillomectomy
- Excision and vaporization of herpes simplex I and II
- Neck dissection
Arthroscopy
Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include:
- Menisectomy
- Synovectomy
- Chondromalacia
Gastroenterology
Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include: منها
15
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
\DĊ. 061218/000001 - 2831829 v2
510(k) Number K090164
8
Page ② of ④
- Hemostasis of upper and lower GI bleeding
- Excision and vaporization of colorectal carcinoma
- Excision of polyps
General Surgery, Dermatology, Plastic Surgery and Podiatry
Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include:
- Matrixectomy
- Excision of neuromas
- Excision of periungual and subungual warts
- Excision of plantar warts
- Excision of keloids
- Liver resection
- Excision of cutaneous lesions
- Hemorrhoidectomy
- Appendectomy
- Debridement of decubitus ulcers
- Hepatobiliary tumors
- Mastectomy
- Dermabrasion
- Vaporization and hemostasis of capillary hemangioma
- Excision, vaporization and hemostasis of abdominal turnors
- Excision, vaporization and hemostasis of rectal pathology
- Pilonidal cystectomy
- Herniorapphy
- Adhesiolysis
- Parathyroidectomy
- Laparoscopic cholecystectomy
- Thyroidectomy
- Resection of organs
- Debridement of wounds
- Photocoagulation of teleangectasia of the legs and face
- Photocoagulation of vascular lesions of the face and extremities
- Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
- Treatment of reticular veins and branch varicosities ()
Urology
Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include:
16
Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090164
\\DC - 061213/000001 - 2831829 v2
9
KOGJ164
ge of (4)
- Vaporization of urethral tumors
- Release of urethral stricture
- Removal of bladder neck obstruction
- Excision and vaporization of condyloma
- Lesions of external genitalia
- Vaporization of the prostate to treat benign prostatic hyperplasia (BPH)
Gynecology
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:
- Endometrial ablation .
- Excision or vaporization of condylomata acuminate .
- Vaporization of cervical intraepithelial neoplasia
- Cervical conization
- Menorrhagia
Neurosurgerv
Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas
Cardiac Surgery
Hemostasis and coagulation of soft tissue, including cardiac tissue.
Pulmonary Surgery
Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:
- Tracheobronchial malignancy or stricture .
- Benign and malignant pulmonary obstruction .
- Endoscopic pulmonary applications
Dental Applications
Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the
17
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
\\DC - 061213/000001 - 2831829 v2
510(k) Number_
er K090164
10
periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.
Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux
Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.
Prescription Use _ X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Oslen Jensen
Page 4 of 4
(Division Sign-Oll) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090164
II. II